At Thermo Fisher Scientific team, you’ll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind
Job Summary
At Thermo Fisher Scientific team, you’ll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind.
The position's focus is to drive compliance and continual improvement of key QMS elements including audit program, change management, customer notifications, quality systems compliance, document control, and training.
This role is based at our Detroit, Michigan campus, supporting our Biologicals and Chemicals Division which maintains ISO 13485 Quality Management System certification.
Matching Summary
At Thermo Fisher Scientific team, you’ll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind.
Skills & Requirements
Must-have
ISO 13485 Quality Management System
Internal and external auditing
Document control and change management
Quality systems compliance
Training program support
Root cause analysis and corrective action
Nice-to-have
Strong critical thinking skills
Technical writing skills
Proficiency in MS Office tools
Team and matrixed environment experience
Driven and resourceful work style
Good time management skills
Key Requirements
Bachelor's Degree, science major preferred
Minimum 2 years Quality Assurance experience in ISO 13485 environment
Auditing experience with ASQ CQA or ISO 13485 Lead/Internal Auditor certifications preferred
Familiarity with life sciences industry
Experience with ERP and electronic document control systems